The Problem of Medicine Quality
There are severe but neglected problems with poor medicine quality globally, but especially for anti-infective medicines in the tropics. These have important but under-recognised impact on public health. Poor quality drugs have clear importance for individual patients, in terms of death, treatment failure, prolonged sickness, excess health expenditure, and lost income. Poor quality drugs also have far reaching consequences for society, resulting in loss of confidence in efficacious medicines and health systems, and economic losses to patients, health systems and the pharmaceutical industry.
LOMWRU conducts random sampling of medicines to objectively estimate the prevalence of falsified and substandard drugs, evaluate new rapid assessment techniques for medicine quality and advocate so that much more is done to improve the quality of the global medicine supply. We host the coordination for the Antimalarial Quality Scientific Group of WWARN to tabulate, map, disseminate and discuss global data on the quality of antimalarial medicines. To contact the coordinator of the WWARN Antimalarial Quality Scientific Group please write to firstname.lastname@example.org.
It has become clearer that there is great heterogeneity in the distribution of poor quality medicines and we are trying to determine their risk factors. In Laos, we work with the Food and Drug Department and Food and Drug Quality Control Centre, in collaboration with Dr Michael Green, CDC-USA and Professor Facundo Fernandez, of Georgia Tech, on the quality of the drug supply in Laos, giving the first objective estimates of the prevalence of poor-quality drugs in the country.
LOMWRU helped coordinate a large collaboration of INTERPOL, scientists, doctors, Chinese police and the WHO to trace the origin of the epidemic of fake artesunate. When the chemical and botanical (pollen) evidence suggested that the fakes were coming from southern China, the Chinese Government launched their own criminal investigation and arrested some of those responsible.
We also act as a coordinating centre for samples of suspected falsified and substandard medicines working with forensic chemists and biologists, regulatory authorities and international organisations. We have recently worked with the WHO to revise guidelines for design and reporting of medicine quality surveys and argued that clinical trial guidelines, such as CONSORT, should include evaluation of the quality of medicines used in trials.